ASTELLAS ANNOUNCES MARKETING AUTHORISATION APPLICATION FOR XTANDI™ (ENZALUTAMIDE) FOR CHEMOTHERAPY-NAÏVE METASTATIC PROSTATE CANCER (pdf 83KB)

On April 3, 2014 Astellas Pharma announces the submission of a variation to amend the Marketing Authorisation Application for XTANDI (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated (Press release Astellas, APR 3, 2014, View Source [SID:1234500365]). Enzalutamide is currently approved in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel chemotherapy.